Oral Versus Intravenous Fluid Therapy in the Emergency Department

NCT07361952 | Recruiting DMC

• 1 other identifier: S-20250042
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this randomized clinical feasibility trial is to determine whether oral fluid therapy can achieve prescribed fluid volumes as effectively as intravenous fluid therapy in adult patients admitted to the emergency department who require fluid treatment. The main questions it aims to answer are: Are patients receiving oral fluids equally likely to achieve the prescribed fluid volume compared with patients receiving intravenous fluids? Is it feasible to conduct a randomized trial of oral versus intravenous fluid therapy in the emergency department, based on recruitment rate and protocol adherence? Researchers will compare oral tap water administration with standard intravenous crystalloid therapy to assess whether oral fluids are non-inferior in achieving prescribed fluid volumes and to evaluate feasibility outcomes. Participants will: Be randomized to receive either oral tap water or intravenous crystalloid fluids during their stay in the emergency department Receive a fluid volume and administration rate determined by the treating physician Be monitored according to standard clinical practice during the emergency department stay Have fluid intake, vital signs, and clinical outcomes recorded, with follow-up through routine health records up to 30 days after inclusion

Conditions

Fluid Management

Keywords

oral fluids; Emergency department; intravenous fluids; fluid management

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department

  From inclusion until end of participation. End of participation is defined as the timepoint of leaving the emergency department or after 48 hours, whichever happens first.

Secondary Outcomes (6)

• Fluids received in the ED (ml)

  From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise

• Fluids received in the ED after inclusion in the study (ml)

  From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise

• Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first.

  8 hours or discharge, whatever comes first.

• Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable)

  30 days

• Mortality at 30 days

  30 days

Study Arms (2)

Intravenous fluids

ACTIVE COMPARATOR

Participants randomized to receive IV crystalloid fluids during ED stay

Other: Intravenous fluids

Oral fluids

EXPERIMENTAL

Participants randomized to receive oral tap water during ED stay

Other: Oral fluids

Interventions

Oral fluids OTHER

Any fluid volume prescribed by the physician during the ED stay is administered orally.

Oral fluids

Intravenous fluids OTHER

Any fluid volume prescribed by the physician during the ED stay is administered intravenously.

Intravenous fluids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• At least 1000 ml of crystalloid fluid therapy prescribed by the physician

You may not qualify if:

• Altered mental state prohibiting oral fluid intake (Glasgow Coma Scale ≤ 12)
• Pregnancy
• Oral fluids contraindicated (e.g. bowel obstruction)
• Severe hyponatremia (sodium \<120 mEq/L)
• Requiring treatment in the intensive care unit

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Odense University Hospital: collaborator
• Hospital of Southern Jutland, Aabenraa, Denmark: collaborator

Study Sites (3)

Emergency Department, South Jutland Hospital

Aabenraa, Denmark

RECRUITING

Emergency Department, Esbjerg Hospital

Esbjerg, 6700, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 23, 2026
• Study Start: October 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available upon reasonable request beginning after publication of the primary results and ending 5 years thereafter.
• Access Criteria: Access to de-identified individual participant data (IPD) and supporting documentation will be granted to qualified researchers upon reasonable request. Requests must include a written proposal describing the research question, planned analyses, and intended use of the data. Proposed analyses must be scientifically sound and consistent with the scope of the original study. Requests will be reviewed by the study investigators to assess scientific merit, feasibility, and compliance with ethical approvals and data protection regulations. Where required, approval from relevant ethics committees or data protection authorities must be obtained prior to data access. Data sharing will be subject to the execution of a data sharing agreement outlining the terms of use, data security requirements, and restrictions on onward sharing. Data will be provided in a secure format and access will be limited to the approved analyses.

Locations

DK (3)